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EU fast-tracks review of Pfizer/BioNTech COVID-19 vaccine

CHMP meeting scheduled for 21 December

The European Medicines Agency (EMA) has scheduled an ‘exceptional meeting’ of its Committee for Medicinal Products for Human Use (CHMP) on 21 December to review additional data for Pfizer/BioNTech’s COVID-19 vaccine.

The move to bring the review forward comes after the vaccine, BNT162b2, gained approval in the US last week and earlier this month in the UK.

The meeting was originally scheduled for 29 December, and the EMA added that this meeting will still take place if needed, but that the CHMP is hoping to conclude the review on 21 December, if possible.

“The CHMP will conclude its assessment at the earliest possible time, only once the data on the quality, safety and effectiveness of the vaccine is sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” the EMA said in a statement.

Yesterday Germany’s health minister Jens Spahn said that the “goal is to get approval before Christmas”, adding that “we want to start vaccinating in Germany before the end of the year”.

In a tweet sent yesterday, European Commission (EC) president Ursula von der Leyen also said that it is “likely that the first Europeans will be vaccinated before the end [of] 2020”.

Last month, the EC signed a contract with Pfizer/BioNTech for the initial purchase of 200 million doses on behalf of all EU member states. This includes an option to secure an additional 100 million doses, set to be supplied when the vaccine has been proven ‘safe and effective’ against COVID-19.

As part of that contract, EU member states can donate doses of the vaccine to lower and middle-income countries or redirect them to other EU countries.

On 15 December, Germany, France, Italy and five other EU state issued a joint statement saying that they will coordinate the start of their COVID-19 vaccination campaigns.

"We agree to coordinate the launch of the vaccination campaign and to rapidly share information between competent national authorities," the ministers said in a statement released by the Italian Ministry of Health.

Article by
Lucy Parsons

16th December 2020

From: Regulatory

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